biobank uk.pdf

22
Sociology of Health & Illness Vol. 27 No. 2 2005 ISSN 0141–9889, pp. 271–292 © Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005. Published by Blackwell Publishing, 9600 Garsington Road, Oxford, OX4 2DQ, UK and 350 Main Street, Malden MA 02148, USA Blackwell Publishing, Ltd. Oxford, UK SHIL Sociology of Health & Illness 0141-9889 © Blackwell Publishing 2005 xxxx 2005 27 2 Original Article Engendering trust in UK Biobank Alan Petersen Securing our genetic health: engendering trust in UK Biobank Alan Petersen School of Sociology, Politics and Law, University of Plymouth Abstract The recent development of genetic databases, or ‘biobanks’, in a number of countries reflects scientists’ and policy makers’ beliefs in the future health benefits to be derived from genetics research. In Britain, however, a proposal for a genetic database, UK Biobank, has been the focus of a number of concerns. Establishing consent and legitimacy for any controversial biomedical research involving the participation of human subjects is difficult; it is however, acute for UK Biobank given the scale of the project and the criticisms levelled at it. Analysing recently published documents pertaining to UK Biobank, this article examines how consent for the project has been discursively framed and how this is reflected in its governance. It is argued that the problem of organising consent has been framed narrowly in terms of adherence to a well-established repertoire of institutional mechanisms which serves to limit debate on the substantive issues at stake. There is little evidence of reflection on the adequacy of such mechanisms for dealing with the unique challenges posed by UK Biobank, including achieving the confidence and participation of a population with diverse perspectives on genetic research. It is concluded that a restricted public discourse about UK Biobank may contribute to a decline in confidence in regulatory systems governing biotechnology and science more generally. Keywords: biobank, genetic database, trust, consent, discourse analysis Introduction According to proponents of the new genetics, genetics knowledge has the potential to revolutionise the practices of medicine and public health. In the wake of the sequencing of the entire ‘genetic code’, in early 2003 (Radford 2003: 8), there have been growing expectations about the development of a

Upload: modolole

Post on 06-Nov-2015

34 views

Category:

Documents


2 download

DESCRIPTION

BioBank UK.pdf

TRANSCRIPT

  • Sociology of Health & Illness Vol. 27 No. 2 2005 ISSN 01419889, pp. 271292

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005. Published by Blackwell Publishing, 9600 Garsington Road, Oxford, OX4 2DQ, UK and 350 Main Street, Malden MA 02148, USA

    Blackwell Publishing, Ltd.Oxford, UKSHILSociology of Health & Illness0141-9889 Blackwell Publishing 2005xxxx 2005272Original ArticleEngendering trust in UK BiobankAlan Petersen

    Securing our genetic health: engendering trust in UK BiobankAlan Petersen

    School of Sociology, Politics and Law, University of Plymouth

    Abstract

    The recent development of genetic databases, or biobanks, in a number of countries reflects scientists and policy makers beliefs in the future health benefits to be derived from genetics research. In Britain, however, a proposal for a genetic database, UK Biobank, has been the focus of a number of concerns. Establishing consent and legitimacy for any controversial biomedical research involving the participation of human subjects is difficult; it is however, acute for UK Biobank given the scale of the project and the criticisms levelled at it. Analysing recently published documents pertaining to UK Biobank, this article examines how consent for the project has been discursively framed and how this is reflected in its governance. It is argued that the problem of organising consent has been framed narrowly in terms of adherence to a well-established repertoire of institutional mechanisms which serves to limit debate on the substantive issues at stake. There is little evidence of reflection on the adequacy of such mechanisms for dealing with the unique challenges posed by UK Biobank, including achieving the confidence and participation of a population with diverse perspectives on genetic research. It is concluded that a restricted public discourse about UK Biobank may contribute to a decline in confidence in regulatory systems governing biotechnology and science more generally.

    Keywords:

    biobank, genetic database, trust, consent, discourse analysis

    Introduction

    According to proponents of the new genetics, genetics knowledge has thepotential to revolutionise the practices of medicine and public health. In thewake of the sequencing of the entire genetic code, in early 2003 (Radford2003: 8), there have been growing expectations about the development of a

  • 272 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    post-genomic medicine and public health practice. Genetics knowledge, it isargued, will lead to the development of new diagnostic technologies anddrugs that will make medicine more predictive and personalised, whileinsight into gene-environment interactions will provide new strategies forlifestyle and risk management. In recent years, many medical and publichealth authorities have endorsed the genetics so-called revolution whilegovernments have committed public funds to exploit the opportunities thisis seen to provide through research and application, for improving the healthof the public. In the UK, evidence of the Governments commitment toexploiting genetics knowledge for the advancement of health can be seen inthe recent Genetics White Paper,

    Our Inheritance, Our Future: Realising thePotential of Genetics in the NHS

    (Department of Health 2003). This documentoutlines a vision of a range of future applications of genetic knowledge,including testing for single gene disorders, improving preventive andmonitoring services for those at risk of developing disease and developingnew drugs and novel therapies (Department of Health 2003: 1219). Thedecision, in 1999, to establish a UK population biomedical collection,comprising genetic and personal medical information, later dubbed UKBiobank, represents a significant move in the effort to realise the potential ofgenetic research. Funded jointly by the Department of Health, the MedicalResearch Council and the Wellcome Trust, this project is predicted to playa substantial role in the prevention, diagnosis and treatment of illness (seeDepartment of Health 2003: 68, The Wellcome Trust

    et al.

    2003: 6). Fromthe outset, however, the project has been the focus of a number of concernsand criticisms, including those in relation to its consultation processes, itsmethodology and access to and use of collected information.

    As with others undertaking controversial biomedical research involvingthe participation of human subjects, the partners of UK Biobank face theproblem of establishing support and legitimacy for their project. A major issueis an apparent decline of public confidence in the governance of biomedicalresearch, especially in the wake of a number of recent highly-publicised health-service scandals such as those involving Alder Hey Hospital in Liverpool,the Bristol Royal Infirmary and Dr Harold Shipman (Weldon 2004: 161).For example, a survey of attitudes of the general public towards science,undertaken by the Office of Science and Technology and the WellcomeTrust, found that while respondents saw the benefits of science and mostwere amazed by its achievements, there was a low level of confidence inregulation and the Government (2000: 33). Increasingly, questions havebeen raised about whether scientists can be trusted and whether researchshould be more tightly regulated. The difficulty of establishing support forcontroversial biomedical research can be seen as an aspect of a more generalproblem of establishing trust in expert authority in late-modern societies.Expert systems depend on trust, which is difficult to maintain in a contextof heightened risk-consciousness and reflexivity (Giddens 1991). As Taylor-Gooby argues, people are less likely than in the past to take expert authority

  • Engendering trust in UK Biobank 273

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    on trust, and are more inclined to challenge the claims of those who oncewould have been relied on as sources of authority because of their profes-sional status or accredited expertise (2000: 9). In recent science debates,public scepticism towards expertise or the decline of trust has been arecurring theme and is seen by some scientists as an impediment to scientificinnovation and development (see, for example, Institute of Ideas 2002). Theissue of restoring trust in science and scientists, and striking a balance betweenthe protection of the public and the facilitation of potentially valuableresearch, has recently preoccupied science groups such as the UKs RoyalSociety as well as policy makers. However, while the problem of establishingconsent and legitimacy for studies involving human subjects is general tobiomedical and genetic research, it is especially acute for UK Biobank giventhe scale of the project and the criticisms that have been levelled at it.

    Analysing a range of published documents pertaining to UK Biobank,this article examines how support for the project is discursively framed andhow this is reflected in its governance. The concept of framing draws attentionto the way in which claims-makers organise facts and claims and ignoreothers, in their efforts to shape public discourse and potentially public policy(Miller and Riechert 2000: 45, Nisbet and Lewenstein 2002: 361). By con-trolling the facts, language, and the images, claims-makers can help createthe judgemental biases that underlie public policy and establish a frameworkof expectations so that individual issues and events take on meaning aspublic issues (see Nelkin 1995: 7273). The creation of such biases is notnecessarily a result of an orchestrated effort by claims-makers to misleadpublics by misrepresenting issues, as is sometimes claimed or implied bycritics of media portrayals of science and technology. Rather, it is likely tooccur through routine, taken-for-granted practices of writing or presentationthat are based on unquestioned assumptions about publics, about what theyneed to know, and about how they are likely to read and understand issues.

    A consideration of context is crucial in the analysis of any discourse: thehistorical and politico-economic conditions shaping the production and dis-semination of texts, and the socio-cultural milieu influencing their reception.Written documents, such as those pertaining to UK Biobank, are a product ofparticular historical and social conditions, and assume meaning and are readin light of shared meanings about genetics and its history and significance.Particular images of genetics, aided by the use of specific metaphors, dominateat different periods, corresponding with broader shifts in conceptions of thebody, self, society and science. Knowledge about genetics and its applicationsis communicated via diverse popular cultural sources, such as television,movies, magazines, diverse news media, and increasingly the Internet (seeConrad 1997, 2001, Nelkin and Lindee 1995, Petersen 2001, 2002, Turney1998, van Dijck 1998). Such sources collectively contribute to the discourseon genetics and its benefits and dangers, which has the potential to influenceaudiences responses to specific initiatives. For example, panic responsesto the announcement of the cloning of Dolly the sheep in 1997, namely

  • 274 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    concerns that the technology would soon be applied to the cloning of humans,were shaped by popular cultural understandings of science and belief in itspower to alter nature (Petersen 2002). Similarly, public reactions to UKBiobank and other genetic databases can be seen to mirror widely-held viewson biotechnology and the potential for its (mis)applications. Throughout itshistory, biotechnology has been influenced by beliefs about its benefits aswell as its dangers. It is very much a product of regulatory regimes andefforts to overcome publics anxieties about its uses and the threats posed tosuch concepts as Nature, the natural and motherhood (Bud 1995: 2945, 306).

    Published documents pertaining to the UK Biobank proposal, most ofwhich are accessible via the web, provide insight into a range of issues andconcerns in relation to the storage and use of personal genetic information.They include reports of public consultations, outputs from governmentenquiries and of the Human Genetics Commission, written evidencepresented by various groups to Parliament, publications released by theprojects partners, press releases and the draft protocol and ethics andgovernance framework documents. A search of the Internet was undertakenat regular intervals between August 2002 and December 2003 in order toidentify pertinent documents, using the keyword Biobank. Publicationsreferred to in collected documents, many of which were also available on theweb, were then retrieved. Informal discussions with officers at UK Biobankassisted in identifying other published literature. Documents were thenanalysed, and note made of the nature of the documents, stakeholders/claims-makers, key themes and use of particular language, metaphors,rhetorical devices and the presence or absence of supportive evidence andof responses to the concerns of critics. The analysis revealed that the UKBiobank project has been discursively framed in overwhelmingly positiveterms, which has been achieved by the use of a specific language and byreference to particular issues and facts. Documents have emphasised theprojects future benefits for the public, its competent management and itsadherence to good practice. Critics substantial concerns have either beenignored or portrayed as having been adequately addressed through dialogueand adherence to the projects ethics and governance framework. Overall,the framing of the problem of organising consent has occurred within a well-established set of principles and practices, which has served to narrow publicdebate about the substantial social and political implications of developinglarge-scale genetic databases for research. Before proceeding further, however,some comments on the historical and contemporary context shaping thedevelopment of UK Biobank and responses to the project are in order.

    Context shaping the development of UK Biobank

    The development of UK Biobank needs to be seen in the context of ahistorically-specific discourse on genetics and its potentialities. This

  • Engendering trust in UK Biobank 275

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    discourse, which began to emerge in the 1980s and 1990s, has focusedsubstantially on the medical and public health applications of geneticresearch (Petersen and Bunton 2002, Condit 1999). The use of the metaphorof the blueprint signalled a shift from the individual gene to the genomeand an exclusive concern with the individual and the family to encompasssocial structure and commercial considerations (Condit 1999: 159177).Developments in communications technologies in the last two decades haveprofoundly shaped views on genetic information and its potential applications.More and more, the image of the genome is of an information system that canbe read and edited. The metaphors of the code and the book becamepredominant, and writers began to refer to the quest to break the geneticcode or to read the genomic book of life. In the 1990s, the Human GenomeProject the mapping of the human genome became a scientific andcommercial priority (Kaye 2000: 327). The fusion of two huge technosciences biotechnology and informatics has provided new explanations of disease,and the possibility of new DNA diagnostics, new pharmacological productsand a new commodity bioinformation (Rose 2001a, b). Digital technologiesare seen as having the potential to unlock the secrets of life (Keller 1992)and to allow for novel possibilities for storing, manipulating and transferringdata. Such technologies have made possible the development of geneticepidemiology, a sub-discipline devoted to the study of gene-environmentinteractions. Stimulated by advances in molecular biology, computertechnology and statistical modelling, genetic epidemiology seeks to describeand explain the distribution of genetic traits and diseases in populations andfamilies. It is a field of research dependent on very large population-basedsample collections and access to detailed patient information such as thatpromised by UK Biobank (see Martin and Kaye 2000: 168).

    The proposal for UK Biobank (originally UK Population BiomedicalCollection) arose out of discussions between the Medical Research Council(MRC) and Wellcome Trust, and the decision, in June 1999, to establish aresearch resource to collect genetic and environmental information using aprospective population cohort study. It was agreed to make this available toresearchers studying the causes of diseases in later life. In 2001, the projectwas enthusiastically endorsed by the House of Lords Select Committee onScience and Technology (Fourth Report) which recommended that theGovernment provide sufficient earmarked resources for the project (Houseof Lords Select Committee on Science and Technology 2001). Funding wasannounced in April 2002, with contributions from the MRC, WellcomeTrust (20 million each) and the Department of Health (5 million) (Parlia-mentary Office of Science and Technology 2002: 12). The contribution ofthe Wellcome Trust and the MRC has since been increased to 28 million(UK Biobank Briefing Note April 2004.) It was proposed that health,genetic, risk and lifestyle information will be collected for at least 500,000participants from the age group 4569 over a 10-year period, with recruitmentexpected to commence in 2005. This age group has been selected so as to

  • 276 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    maximise the number of illnesses and deaths recorded (Parliamentary Officeof Science and Technology 2002: 1). A document published by the projectsfunders notes that participants will be randomly approached via their familydoctor, after discounting people whom it would not be appropriate to contact,and will be sent a letter asking them to take part in the study. Further, it notes,Not all GP practices will participate in the study the aim is to get arepresentative sample from different areas of the country (MRC

    et al.

    2003: 2).The projects participants will be followed up periodically and informationwill be tracked against the participants medical records, so that researcherswill be able to study the interplay between the participants genes, lifestylesand the diseases and conditions they may develop (MRC

    et al.

    2003: 3).The concept of a database that includes genetic and personal medical

    information, it should be noted, is not entirely novel. For over 30 years,registers of patients with genetic diseases have been established in a numberof countries (WHO 2002: 113114). Current and planned research projectsfocus on particular diseases and on samples of varying size and use personalmedical information to different degrees (Martin 2001: 165169, Martin andKaye 2000: 16976). However, the new generation of genetic databases, suchas UK Biobank, differs in scope, format, and size, and in many cases involveextremely large populations (WHO 2002: 114). A recent international studyof eight proposed genetic databases (including UK Biobank) found thatwhile the databases had a common goal (to search for susceptibility genesfor complex diseases, improve health and medical care in the region, andto stimulate the local economy through expansion of the biotechnologysector), they differed in certain respects, including funding, organisation,subject participation, level of government and commercial involvement, andpopulation makeup and size (50,000 to one million participants) (Austin

    et al.

    2003: 42). Such databases, however, require as their ideal preconditiona universal healthcare system, general in the old welfare states, which havethe required universal healthcare records (Rose 2001a: 123).

    The role of the commercial sector, and ownership and access to data

    As Martin (2001) notes, a feature of clinically-based human genetics researchto date has been a strong interdependence between the private and publicsectors. The former relies on the latter (in the UK, the NHS) to get accessto biological samples and human subjects, while the latter rely on the formerfor the commercial exploitation of publicly-funded research. Close academic-industry links have been a feature of a number of large-scale geneticdatabases to date;

    e.g.

    Iceland (deCODE), France (Genset), Sweden (Uman-Genomics) and the USA (Genomics Collaborative) (Austin

    et al.

    2003: 3942; Martin 2001: 170). In the UK, funders of research are generally keen onthe commercial exploitation of publicly-funded research and on makingresearch resources, such as large sample collections and genetic databases,readily accessible to industry (Martin 2001: 169). Although, in August 2004,the framework governing intellectual property and access was in the process

  • Engendering trust in UK Biobank 277

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    of development, the draft UK Biobank Ethics and Governance Frameworkmakes clear that ownership of the database and the sample collection willremain with UK Biobank Limited (UK Biobank was established as acompany in December 2003.) As the Framework document states, Suchownership conveys certain rights, such as the right to take legal actionagainst unauthorised use or abuse of the database and samples, and the rightto sell or destroy the samples. Further, it notes, Participants will not haveproperty rights in the samples. However, UK Biobank does not intendto exercise all of these rights; for example, it will not sell samples (TheWellcome Trust

    et al.

    2003: 18). UK Biobank proposes to charge all usersan access fee, calculated on a sliding scale, so that total costs are propor-tionate to level of use (personal communication, Professor John Newton,Chief Executive, UK Biobank 26 February 2004). While, during the earlystages of the project, the commercial sector had shown little apparent inter-est in the project, this may change as the project progresses. The BioindustryAssociation, which is the trade association for innovative enterprises in theUKs biosciences sector, announced its support for the project, in a PositionPaper on UK Biobank, published in May 2003. It commented that, Amajor potential benefit of Biobank is the development of new medicines,diagnostics and treatments that could benefit the publics health. Theinvolvement of pharmaceutical and biotechnology companies is thereforeessential in order to maximize potential health benefits from Biobank (TheBioindustry Association 2003: 4).

    While academic-industry links may facilitate technology transfer acrosssectors, they can also generate anxieties about academic conflicts of interestand commercial monopoly (Martin and Kaye 2000: 169). The IcelandicHealth Sector Database, for instance, has been the subject of considerablecontroversy, related in part to its market-driven approach, as well as to thepresumed consent of the population (Rose 2001a, b). As Rose notes, globalplayers such as SmithKline Beecham (now GlaxoSmithKline), and leadingfigures in UK science, have had the advantage of seeing problems generatedby the approach of the Icelandic case. This has led them to recognise theneed for new hybrid structures between the state and the market and to workslowly and consensually to get the support of all constituencies (Rose 2001b:67). They have supported the development of appropriate ethical andregulatory protocols and called for greater public understanding of patentingissues in relation to genetic information. In its written evidence to the Houseof Lords enquiry, Human Genetic Databases: Challenges and Opportu-nities, submitted in 2000, SmithKline Beecham argued that concernsexpressed about industry involvement in genetic database initiatives can beassuaged by incorporating the best practice developed by companies suchas SB. In SmithKline Beechams view, this could be achieved by protectionof patient privacy and confidentiality and using an opt-in approach toparticipation based on informed consent. It also saw a need to correct [sic]the widespread misunderstanding that raw gene sequence information can

  • 278 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    be patented and that the patent holder in some way owns that sequence asit exists in individuals (House of Lords Select Committee on Science andTechnology 2000: 2, 7).

    UK Biobank has been developed in a context of significant culturalresistance to the commodification of the body and its parts associated withbiotechnology and fears about its implications (Boyes 1999, Hansen 1999,Nelkin and Andrews 1998, Plsson and Har

    d

    ardttir 2002, Whitt 1998).Opinion polls suggest widespread suspicion about the use of human subjectsfor DNA research along with worries about ethics and privacy (Everett2003: 2). The ability of genetic databases to store data over the longer term,and to link genetic information with health information, and potentially withother data such as police and employment records, is of particular concernto a number of groups. During the planning of UK Biobank, individualsand researchers felt that some people may be deterred from participation ingenetics research if police are able to compare DNA recovered from crimescenes with donor samples (Department of Health 2003: 689). UK Biobankhas received some critical media attention in relation to these and other issues.For example, an article, Fury at plan to sell off DNA secrets, appeared onthe front page of

    The Observer

    in September 2001 (

    i.e.

    some months before theannouncement of the funding of UK Biobank). The article noted that, Thegenetic secrets of millions of Britains could be sold off to private drug com-panies under highly controversial proposals outlined in leaked governmentdocuments. It referred to campaigners concerns that such information couldpotentially be leaked to the police, employers or insurance companies, andwould be a step to privatising the nations DNA (Barnett and Hinsliff 2001: 1).

    In 2002, GeneWatch UK, a not-for-profit public interest group devotedto the ethical and safe use of genetic technologies, questioned whether theproject is a good use of public money and argued that it could underminepublic trust in medical research (GeneWatch UK 2002). It drew attentionto scientific objections with the project, the absence of assessment of alter-native population-based measures, the potential for discrimination and lossof privacy and the need for legal safeguards before volunteers were asked todonate their samples to UK Biobank (GeneWatch UK 2002: 23). Scientiststhemselves have had divided views on aspects of UK Biobank. While somehave been broadly supportive of the project and believe that it is scientificallyvalid, others have seen it as politically conceived, as costly, and as inefficientfor the investigation of many of the diseases that are likely to be of greatestinterest (Barbour 2003: 1737). Criticisms have been made about the researchdesign, the process of awarding contracts for the participating scientificgroups who will collect the data (the project will involve a central hub inManchester and six regional spokes), and an apparent unwillingness toaddress criticisms of the project which has created a great deal of uneaseamong scientists, even those who support it (Barbour 2003: 1738). And, inMarch 2003, the House of Commons Select Committee on Science andTechnology strongly criticised the project on a number of grounds, and

  • Engendering trust in UK Biobank 279

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    suggested that a scientific case for Biobank has been put together by thefunders to support a politically driven project (2003: 4).

    Investing in the publics health

    It is against this background of concerns about the project that proponentsof UK Biobank have endeavoured to highlight the projects potential benefitsand its inclusive and ethical nature, making use of particular language andmetaphors. Published documents describe the project as an investment, aresource, and a national asset, exploiting the insights derived from theHuman Genome Project, for potential significant economic and public healthoutcomes in the future. In its submission to the House of Lords Select Com-mittee on Science and Technologys enquiry on human genetic databases, theSanger Centre (which contributed to the sequencing of the human genome)emphasised the projects potential economic benefits. It drew attention toinitiatives in the USA and to the serious economic and political risk inallowing one country to take sole charge of such an important resource(House of Lords Select Committee on Science and Technology 2000). In itsFourth Report, the House of Lords Select Committee on Science andTechnology used a similar economic argument (it is vital for scientific,medical and economic reasons to maintain this competitive advantage) injustifying its support for research involving human genetic databases (2001:4.31). The

    Protocol for the UK Biobank

    notes that Biobank represents asubstantial, broad and accessible

    investment

    in post-genome research andthat the project will serve to develop national expertise and infrastructure ingenetic and molecular epidemiology (The Wellcome Trust and MRC 2002:30, emphasis added). The Human Genetics Commission (HGC) argues thatlarge-scale population genetic databases, established with and supported bypublic funding, constitute a

    national asset

    (HGC 2002: 24; emphasis added).The use of bank in UK Biobank, indeed, suggests that the collected in-formation will prove to be an investment or asset, benefiting individualinvestors and the community as a whole.

    Above all, UK Biobank is promoted as a significant

    resource

    for research.The Background Document for the UK Biobank Ethics and GovernanceFramework describes UK Biobank as an ambitious project to build a largemulti-purpose data resource (Interim Advisory Group, 2003: 3). The draftFramework itself notes that the UK Biobank aims to build a majorresource to support a diverse range of research that will in turn improve theprevention, diagnosis, and treatment of illness and the promotion of healththroughout society (The Wellcome Trust

    et al.

    2003: 6). In its writtensubmission to the House of Lords Science and Technologys enquiry intohuman genetic databases, the Wellcome Trust describes UK Biobank as anexperiment in how genome information may be exploited with broaderimplications for future health care. It says that the project is a model

  • 280 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    experimental approach to the future enhancement of links between genomicinformation and patient care, including the introduction of pharmacogenomicapproaches to treatment and therapy and could be a testing ground forfuture NHS database developments (House of Lords Select Committee onScience and Technology, 2000).

    The projects partners have been at pains to underline the projectsscientific significance, its uniqueness and timeliness, and its potentially usefulmedical and public health applications, using language that underlines itsmomentous impact:

    As the

    largest and most comprehensive prospective study

    with biological samples in the world, the UK Biobank is

    expected to contribute substantially to international knowledge

    regarding the combined effects of genotype and exposure on the risk of disease . . .

    . . .

    A unique and timely opportunity therefore exists

    for the setting up of a large study incorporating information on genetic factors and an individuals health and exposure history.

    Due to the unique combination of a large population and a centralised National Health Service, the United Kingdom is in an ideal position to conduct such a study

    . . .

    . . . Improved means of preventing, screening for and treating these conditions arising from the UK Biobank

    will have far reaching implications for the health of the public and the health of individuals

    . . . (The Wellcome Trust & MRC 2002: 6, 8; emphases added).

    It will take a number of years to build a strong foundation for the project but the study

    will provide valuable information

    on the factors contributing to diseases affecting the middle aged and elderly . . . The databases of lifestyle and health information

    will also be very useful for public health research

    .

    . . . Picking apart this complexity requires a study to be on a huge scale. In time it will help us understand . . . This understanding will

    help in designing new preventive interventions

    and knowing who would

    benefit the most

    . It may also

    help in the design of a new generation of drugs

    to counter most major diseases (MRC

    et al.

    2003; emphases added).

    The Chief Executive of UK Biobank, Professor John Newton, has alsoemphasised the projects significance as a research resource and a contributorto the public health endeavour, in a press release statement on the geneticsWhite Paper,

    Our Inheritance, Our Future

    :

    . . . The UK Biobank will be among

    the first and certainly the largest post-genome resource

    to study the roles of both nature and nurture in health and disease. As a population study, it will be used by the research

  • Engendering trust in UK Biobank 281

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    community to generate the practical intelligence required for 21

    st

    century public health strategies. Responsibly run projects like the UK Biobank are essential if we are to make the best use of the human genome information. They will

    help ensure that the opportunities for public health provided by these new developments are not squandered

    (Press release, The Wellcome Trust June 2003, emphases added).

    As these excerpts show, strong assurances are offered about the potentialscientific value and public health benefits of the project. However, readersare provided with few details about the nature of these benefits and noevidence of beneficial outcomes from similar smaller genetic databasesdeveloped in the past. There is no acknowledgement of the complexities ofthe genetic basis of common diseases that some writers believe will makeaccurate prediction difficult if not impossible (Holtzman and Marteau 2000).Further, there is no mention of the potential difficulties of disentanglinggenetic and lifestyle contributions and of how environmental determinantswill be assessed. Potential problems with undertaking research on a samplecombining lifestyle information, which is qualitative and context dependent,with the hard data of DNA was raised in Parliament in 2002. It was notedthat there is a danger of relying on research participants patchy recollectionsof past behaviour and exposure to environmental risks that will make itdifficult to disentangle genetic and environmental factors, which haveimportant implications for the findings of Biobank. The fear expressed wasthat it will skew towards over-emphasising the genetic influence on diseaseprocesses because it is the only thing on which Biobank will provide harddata (Gibson, Hansard 3 July 2002). Despite the expression of such concerns,the science informing the project remains unquestioned, and potential social,ethical and legal problems associated with the long-term storage of personalgenetic information receive no mention. Here, as elsewhere, the public isassured that UK Biobank is acting for the common good and that anybenefits will be shared and income invested. The first public draft of theUK Biobank Ethics and Governance Framework, for example, notes, undera heading Benefit sharing, that the biotechnology and pharmaceuticalindustries can play an important role in realising health benefits in a practicalsense, by developing and improving the use of biomedical products. Further,Any income that UK Biobank secures from access fees or intellectual pro-perty will be invested in the resource (The Wellcome Trust

    et al.

    2003: 278).

    Consulting the public

    The UK Biobank partners have endeavoured to demonstrate the seriousnesswith which they have considered the views of the public on the project.Consequently, they have undertaken a number of consultations. This hasinvolved a combination of methods. First, one-to-one in-depth interviews

  • 282 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    with the general public from across Great Britain as well as more specificgroups (

    e.g.

    people with disabilities or diseases, religious and communityleaders) was undertaken in 2000, as well as a survey of GPs and practicenurses about their role in the project. Group discussions (each with about 20people) with people from the relevant age group (4569) from Hertfordshire,the West Midlands and Glasgow were then conducted in 2002 to explorethe ethical and management issues. A summary of the findings of theconsultations was posted on the web, and an assurance was offered thatconsultation is an on-going process: The findings represent

    the beginning ofan in-depth consultation with the public and professional groups

    , which willhelp to inform the development of the UK Population Biomedical Collection(The Wellcome Trust and MRC 2000: 2, emphases added).

    These consultations revealed some unease about genetics research ingeneral: as a scientific activity it seemed mysterious and sinister. More specif-ically, it was linked to cloning, genetically modified foods, and designerbabies (The Wellcome Trust and MRC 2000: 3). Although, according to onereport, people were found to be favourably disposed to the idea of researchper se, views of genetic research were varied. While some felt that it hadpotential benefits, others expressed reservations, some more serious thanothers. The report noted that, Concerns were greatest in the context ofresearch on certain genetic therapies and on disabilities, particularly wherethese are identified before birth (2000: 3). People were found to have mixedviews about the Wellcome Trust and MRC proposal. A range of specificissues of concern were raised, including possible misuse of samples forcloning or other questionable purposes, potential discrimination against dis-abled people, loss of participants anonymity, profiteering by pharmaceuticaland biotechnology companies, and employers and insurers gaining access toinformation and misusing it. The report noted that some special interestgroups also questioned the involvement of the MRC and the WellcomeTrust in the project, believing that both organizations were subject to pressurefrom pharmaceutical companies and the Government, and too willing towork to an agenda against the interests of people with disabilities (2000: 4).However, These worries were often allayed by explanation of why informa-tion would be helpful to researchers, and by reassurances of safeguardsagainst unauthorized access (2000: 45).

    Consultations undertaken by People Science and Policy Ltd (2002) forthe MRC and the Wellcome Trust revealed particular concerns aboutcommercial involvement in the project. The consultants report noted thatpeople were worried that companies would focus on profitable diseasesrather than major healthcare issues and wondered whether it would person-ally benefit them (2002: 3). As in the other, earlier consultation exercise, thesceptical participants are offered reassurances:

    There were questions about whether companies could sell the data on. However, participants thought that it would not be in the interests of the

  • Engendering trust in UK Biobank 283

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    Wellcome Trust and MRC to let this happen. The project team assured participants that terms and conditions could be put on the use of the data to prevent this (People Science and Policy Ltd, 2002: 21).

    A range of consultative methods, including interviews, surveys and focusgroups, have been used extensively in recent years by various authorities andgroups including the Wellcome Trust to ascertain public views on scienceand other issues (see, for example, Bailey 2001, Coote and Lenaghan 1997,Joss and Durant 1995). By being seen to consult the public through theabove means and then making findings accessible (for example, on the web)and, where necessary, offering assurances and explanations, the UK Biobankpartners have been able to present themselves as acting openly and demo-cratically and taking cognisance of public concerns. The adequacy of thisprocess and the assumptions that underlie it are never scrutinised. There isno acknowledgement of the limitations of such consultative mechanisms,including problems with their assessment, and questions about whether theparticipant groups are representative of the populations from which they aredrawn (Petersen and Bunton 2002: 18890). Despite discovering a numberof specific worries about UK Biobank during its consultations, theprojects partners do not always explain how these will be taken into accountin the subsequent development of the initiative. Significantly, the Houseof Commons Select Committee recently questioned the adequacy of UKBiobanks public consultation processes. It commented:

    It is our impression that the MRCs consultation for Biobank has been a bolt-on activity to secure widespread support for the project rather than a genuine attempt to build a consensus on the projects aims and methods. In a project of such sensitivity and importance consultation must be at the heart of the process not at the periphery (House of Commons Select Committee on Science and Technology 2003: 7).

    Use of the language of citizenship

    In their arguments for UK Biobank, proponents have made extensive useof the language of citizenship, particularly in references to participantscontribution to helping others and to altruism. The first public draft Ethicsand Governance Framework (EGF) for UK Biobank, released for commentin September, 2003 noted that, Participation will be cast as

    an opportunity tocontribute information that in the long term may help enhance other peopleshealth

    (The Wellcome Trust

    et al.

    2003: 9, emphasis added). In the publishedminutes of a consultation with UK industry (UK Biobank: Consultationwith Industry Workshop), the potential benefits for others in the future areagain emphasised: The UK Biobank is a long term endeavour and

    thealtruistic contribution of participants will benefit future generations

    . In the

  • 284 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    same paragraph, it is noted that, The contribution of participants to theproject should be seen as a

    gift to biomedical science in the public interest

    (Minutes of consultation with industry workshop 4 April 2003: 4, emphasesadded). These references to research participants altruistic contribution tothe health of future generations mirror those found in other recent publica-tions on genetic research.

    For example, the Human Genetics Commission report,

    Inside Information

    ,notes, in a section, General principles for the way we treat personal geneticinformation:

    Genetic knowledge may bring people into a special relationship with oneanother . . . Sharing our genetic information can give rise to opportunitiesto help others and for other people to help us and we have a commoninterest in the benefits that medically-based genetic research may bring.We have, therefore, set out a concept of

    genetic solidarity and altruism

    .This supports the idea that, for example, although nobody should feelpushed into taking part in genetic research, when they make this decisionpeople should be aware that by taking part they might help those sufferingfrom disease (HGC 2002: 7, emphases in original).

    Words and phrases such as altruistic, gift, sharing, opportunities tohelp others, common interest, help those suffering from disease and so on,have strong resonance in liberal democracies, especially with a broadeningof the concept of social citizenship and an emphasis on citizen duties(Petersen and Lupton 1996: 13). Use of the term genetic solidarity, used atvarious points in the

    Inside Information

    report, however, would seem tosignify a substantial modification of the concept of

    social

    solidarity formu-lated during the development of the welfare state. The term solidarity in itsconventional usage implies cohesion, the sharing of aims and interests, andsingle-minded unity of purpose (Marshall 1994: 503). The use of geneticmay seem odd when used in conjunction with solidarity, but is consistentwith what Miringoff (1991) has identified as the increasingly prominentworldview of genetic welfare, whereby genetic considerations tend toprevail over social ones and there is a change in our perceptions of rights,responsibilities and duties. It is the language of an emergent biologicalcitizenship, involving the linking of biology and identity (Petryna 2002: 14).

    The concept of genetic solidarity and altruism emphasises the mutualityof interest in promot[ing] the

    common

    good: This sharing of our geneticconstitution not only gives rise to opportunities to help others but it alsohighlights our common interest in the fruits of medically-based geneticresearch (HGC 2002: 16). The above reference to the gift to biomedicalscience in the public interest, suggests, following Titmusss (1970) classicformulation of blood donation in the British welfare state, a transactionwhich stands outside economic calculation and which carries no explicitright, expectation or moral enforcement of a return gift (citing Frow 1997:

  • Engendering trust in UK Biobank 285

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    105). However, interestingly, this position conflicts with a view expressedearlier by the Human Genetics Commissions report,

    Whose Hands onYour Genes?

    , that raised the question of whether the donor of a samplegiven purely for research purposes makes a gift of the sample (eitherunconditional or with conditions specifying what it might be used for)(2000: 24). An unconditional gift, it explained, entitles the recipient to dowhat he or she wishes to do with it, in the same way as the recipient of anordinary gift may use the gift as he wishes. However, it noted that, Thisview conflicts with current moral opinion, the clear direction of which is torecognise that the donor has a moral interest in what is done with bodilysamples (HGC 2000: 24).

    Informed consent and rights

    Evidently recognising that participants in UK Biobank have a moral as wellas a personal health interest at stake, the Group that prepared the firstpublic draft UK Ethics and Governance Framework have been at painsto spell out participants rights in relation to informed consent and tosharing the benefits of the information that has been donated. The draftFramework emphasises that the consent of participants will be based on anexplanation and understanding of the purpose of UK Biobank and thevarious policies and practices governing its activities (The Wellcome Trust

    et al.

    2003: 910). The Background document to the Framework, however,acknowledges the difficulties of conditional consent;

    i.e.

    consent that letsparticipants choose variously to allow use of some data about themselvesbut not other data, or by certain kinds of researchers but not others, or forcertain purposes but not others (Interim Advisory Group 2003: 7). Itnotes that, Given the large organisational and long time scales of the UKBiobank project, and the involvement of diverse participants around theland, contacted via many different channels, and data potentially being usedin hundreds of research projects, participation will have to be all or nothing

    i.e.

    participants will have to be either

    in

    or

    not in

    UK Biobank (2003: 7,emphases in original). Further, in relation to participants access to data onmedical records, it is argued that the project must proceed and be presentedemphatically as being a research endeavour, not a healthcare endeavour.Nevertheless, it notes, It would seem that a few pieces of information almostunavoidably must be given to volunteers. An example is when bloodpressure is taken during the enrolment meeting where, it would be odd,perhaps even offensive, to take the readings but not tell the person wearingthe blood-pressure cuff what they are (Interim Advisory Group 2003: 8).

    Clearly, the co-ordinators of UK Biobank have been presented with an arrayof novel ethical and regulatory challenges in the development of this project,related to its large participant group, long time-span, and the need adequatelyto address concerns about the use and security of collected information.

  • 286 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    Consequently, the first public draft Ethical and Governance Frameworkincludes considerable discussion about such issues as selection and consentprocedures, provision of health information to participants, participantsrights, confidentiality, stewardship of data and samples, research access todata and samples, management and accountability, external governance andbenefit sharing. It also proposes a strategy for handling contingencies inthe event that UK Biobank has to close or make other substantial transitionsin the holdings or control of the resource (The Wellcome Trust

    et al.

    2003).Because it has a number of unique features, UK Biobank has been forcedto chart new terrain in the governance of genetics a point stressed byProfessor John Newton, Chief Executive of UK Biobank, at the launch ofthe Framework; namely, that it will set a new standard for ethics andgovernance in this area (MRC 2003).

    Assurances are offered that consent will be freely given and fully informedand that information will be secured and only used for research that is likelyto improve health. In particular, proponents have emphasised differencesbetween UK Biobank and the Icelandic Health Sector Database, which, asnoted, has been the source of controversy, in consent procedures and in viewson ownership and use of material. For example, The Wellcome Trust, in itswritten evidence to the House of Lords Select Committee enquiry on geneticdatabases, acknowledged negative public responses to Icelands approach tothe storage and use of patient records;

    i.e.

    automatic opt-in. It noted that thishad led to some public antagonism and subsequent international responseto the project especially in terms of links to commercial exploitation. Aparticular strength of the UK project, it argued, was an opt-in voluntaryapproach; however, feedback and communication will be necessary to main-tain the patient volunteers commitment and contact with the organisation inthe long-term (House of Lords Select Committee on Science and Technology2000). In the first public draft Ethics and Governance Framework, it is notedthat UK Biobank will develop an overall policy and detailed terms of refer-ence, addressing fairness and transparency of decision-making, the handlingof conflicts of interest and the prioritisation of use of samples. UK Biobankis described as a steward of the resource whose purpose is to generate anddisseminate new knowledge to benefit the health of the public in the UK andelsewhere (The Wellcome Trust

    et al.

    2003: 18, 27). In short, proponentshave emphasised the open and democratic nature of the project voluntaryparticipation, feedback and communication and its commitment to thepublic good. There is an evident attempt to distance the project from theIcelandic Health Sector Database that was the focus of much critical atten-tion and to help dispel any concerns that people might have about coercion,commercial profiteering and the improper use of information.

    Trust us

    In brief, the message conveyed by the published literature on UK Biobankis that the project is ethically sensitive, competently managed and oriented

  • Engendering trust in UK Biobank 287

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    to the broader public interest; that is, worthy of our trust. Pronouncementsof adherence to ethical procedures appear repeatedly in published documentsrelating to UK Biobank, offering reassurance to potentially anxious publics.Singly and in combination, these pronouncements lend the impression thatethical issues have been carefully considered in relation to issues of consent,confidentiality, security of data and feedback of information to participants.The website for the UK Biobank,

    A Study of Genes, Environment and Health:Frequently Asked Questions

    , offers further reassurances in this regard. Itprovides 18 questions and answers covering the programme, including whatis required of participants and the use of and access to information. Thequestion-answer format, with carefully crafted responses, assists in dispellingany doubt that people may have about the assurances that are offered. Forexample, in response to the question, Who will own the information andwho will be able to use it?, it notes:

    UK Biobank will be the legal owner of the database and the sample collection. Participants will not have property rights in the samples and this will be explained at the outset before they consent to participate. In practice, UK Biobank will serve as the steward of the resource, maintaining and building it for the public good in accordance with its purpose. UK Biobank will not proscribe any research uses at the outset. However, it will insist that all research to be undertaken using the resource be subjected to peer review of their scientific quality, ethical review by an NHS Multi-Centre Research Ethics Committee, and review by UK Biobank to ensure they are consistent with the participants consent, UK Biobanks purpose and an Ethics and Governance Framework. UK Biobank will maintain active communication with participants and the wider public and will strive to build a relationship of trust in order to foster acceptance of the ways in which the resource is developed and used (http://www.ukbiobank.ac.uk/FAQs.htm).

    In this response and the other responses, the assumption is that we, thepublic, can trust the projects co-ordinators to do the right thing by usand that the assurances offered about the benefit and safety of the projectcan be believed. The question of whether the frequently asked questionsare indeed the ones that people would wish to ask, and whether theresponses are satisfactory remains to be seen.

    Conclusion

    Scientists and policy makers face a major challenge in establishing consentand legitimacy for controversial biomedical research involving the participa-tion of human subjects. As noted, this problem is acute for UK Biobankgiven its scale and the various criticisms made of the project. In light of this,

  • 288 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    the projects proponents have endeavoured to frame the project in positiveterms. First, a range of documents pertaining to UK Biobank emphasise theprojects scientific significance, its value as a resource, and its future publichealth benefits, thus conveying the message that the project is deserving ofsupport. Second, the project is portrayed as being inclusive and as sensitiveto the concerns and welfare of the public. The problem of organisingconsent, however, has been framed narrowly in terms of adherence to a well-established repertoire of institutional mechanisms, such as consultationsand the use of advisory groups. There is little evidence of reflection on theadequacy of such mechanisms for dealing with the unique challenges ingaining consent and legitimacy for UK Biobank, given its scale and thevarious criticisms and concerns raised. There is no acknowledgement of theexistence of multiple publics and diverse and often conflicting perspectiveson, and interests in relation to, new genetic technologies and their applica-tions, and of the different ways in which public opinion about genetics maybe gauged (see Condit 2001).

    The regulatory response to UK Biobank, and to other controversialbiotechnology research undertaken in Britain in recent years, has beensubstantially shaped by the 1999 controversy surrounding GM crops. Thiscaught policy makers unaware and led to an overhaul of the frameworks ofgovernance for biotechnology. An advisory and regulatory framework hasbeen developed, with an emphasis on transparency, and dialogue betweenregulators, policy makers, industry, interest groups and consumers (Weldon2004: 171). For instance, the Human Genetics Commission, the UK Gov-ernments advisory body on human genetics (including genetic databases),was created in part for the purpose of consulting and engaging in debatewith citizens about the future of biotechnology in Britain (Weldon 2004:171). As in the US, the emergence of commissions as decision-makers andan emphasis on a principle-based system of ethics has served to thinpublic debate (Evans 2002). Substantive (thick) debates about the ultimateends of human genetic research are obscured by a focus on formal rational(and universalist) arguments about the most efficacious means of achievingpredetermined or assumed ends such as autonomy (Evans 2002: 13). Thequestion of how to best ensure informed consent, for example, has beenposited as a fundamental issue confronting UK Biobank, despite recogniseddifficulties of applying principles of consent, which were developed in themedical context, to population collections (see, for example, Chadwick andBerg 2001, Kaye 2004, Weldon 2004).

    UK Biobank offers important insights into how scientists and policymakers may seek to engender trust in biotechnology research which iscontentious and which raises novel problems for governance. To date, thereis no agreement internationally on the regulation of genetic databases orpractical advice on how to manage them (Callan and Gillespie 2004: 4). Inthis context, it is important to understand how proponents of such collec-tions may seek to establish legitimacy for projects and how projects are

  • Engendering trust in UK Biobank 289

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    governed to reflect this. If expert systems of knowledge depend on trust,which in late modern societies is liable to be withdrawn, as Giddens (1991)argues, then it is important for sociologists to understand how authoritiesseek to establish trust and the likely implications for future biotechnologyresearch of a decline in trust. As noted, genetic research databases are notnew in the UK. However, large-scale population collections such as UKBiobank are novel in their scale, organisation and long time span whichpresents many uncertainties and risks and challenges for their governance.A restricted public discourse about UK Biobank, both its potential benefitsand its dangers and limitations in solving major health problems may notonly adversely affect public responses to this project but also contribute to adecline of public confidence in the regulatory systems governing biotechnol-ogy and science more generally. In short, the question of how UK Biobankengages diverse publics, and how it is seen to address the particular concernsand criticisms that are raised, may determine whether people in the futurewill feel confident in entrusting authorities to secure their genetic health.

    Address for correspondence: Alan Petersen, School of Sociology, Politics andLaw, Faculty of Social Science and Business, University of Plymouth, PL4 8AAe-mail: [email protected]

    Acknowledgements

    I wish to thank Shirlene Badger for our early discussions about this article and forsuggesting a number of references. I thank Professor John Newton and Dr ShaunGriffin, from UK Biobank, for offering some useful items of information on theProject. Finally, I am grateful to the referees for their encouraging comments andvaluable guidance for revision.

    References

    Austin, M.A., Harding, S. and McElroy, C. (2003) Genebanks: a comparison ofeight proposed international genetic databases, Community Genetics, 6, 3745.

    Bailey, P. (2001) The peoples science: involving consumers in scientific research,Wellcome News, 26, 67.

    Barbour, V. (2003) UK Biobank: a project in search of a protocol?, The Lancet, 361,17 May, 17348.

    Barnett, A. and Hinsliff, G. (2001) Fury at plan to sell off DNA secrets, TheObserver, 23 September, p. 1.

    Boyes, M. (1999) Whose DNA? Genetic surveillance, ownership of information andnewborn screening, New Genetics and Society, 18, 2/3, 14555.

    Bud, R. (1995) In the engine of industry: regulators of biotechnology, 19701986.In Bauer, M. (ed.) Resistance to New Technology: Nuclear Power, InformationTechnology and Biotechnology. Cambridge: Cambridge University Press.

    Callan, B. and Gillespie, I. (2004) Biobanks: from health protection to data protec-tion, OECD Observer, 6 February, 16.

  • 290 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    Chadwick, R. and Berg, K. (2001) Solidarity and equity: new ethical frameworks forgenetic databases, Nature Reviews Genetics, 2, 31821.

    Condit, C. (1999) The Meanings of the Gene: Public Debates about Human Heredity.Madison, Wisconsin: The University of Wisconsin Press.

    Condit, C. (2001) What is public opinion about genetics?, Nature Reviews Genetics,2, 81115.

    Conrad, P. (1997) Public eyes and private genes: historical frames, news construc-tions, and social problems, Social Problems, 44, 2, 13954.

    Conrad, P. (2001) Genetic optimism: framing genes and mental illness in the news,Culture, Medicine and Psychiatry, 25, 22547.

    Coote, A. and Lenaghan, J. (1997) Citizens Juries: Theory into Practice. London:Institute for Public Policy Research.

    Department of Health (2003) Our Inheritance, Our Future: Realising the Potential ofGenetics in the NHS. Presented to Parliament by the Secretary of State for HealthBy Command of Her Majesty, June 2003. London: Department of Health and NHS.

    Evans, J. (2002) Playing God?: Human Genetic Engineering and the Rationalization ofPublic Bioethical Debate. Chicago and London: The University of Chicago Press.

    Everett, M. (2003) The social life of genes: privacy, property and the new genetics,Social Science and Medicine, 56, 1, 5365.

    Frow, J. (1997) Time and Commodity Culture: Essays in Cultural Theory and Post-modernity. Oxford: Clarendon Press.

    GeneWatch UK (2002) Biobank UK a good research priority?, Human Geneticsand Health, Parliamentary Briefing, 3 November. (http://www.genewatch.org/HumanGen/Publications/MP_Briefs.htm#MP_3)

    Gibson, I. (2002) Petition on Biobank: House of Commons Hansard Debates, 3 July2002. (http://www.publications.parliament.uk)

    Giddens, A. (1991) Modernity and Self-Identity: Self and Society in the Late ModernAge. Cambridge: Polity Press.

    Hansen, M.J. (1999) Biotechnology and commodification within health care, Journalof Medicine and Philosophy, 24, 3, 26787.

    Holtzman, N.A. and Marteau, T. (2000) Will genetics revolutionize medicine?, TheNew England Journal of Medicine, 343, 2, 14144.

    House of Lords Select Committee on Science and Technology (2000) Science andTechnology Written Evidence (6 November) (http://www.parliament.the-station-ery-office.co.uk/pa/ld199900/ldselect/ldsctech/115/115we01.htm)

    House of Lords Select Committee on Science and Technology (2001) Science andTechnology Fourth Report (20 March) (http://www.publications.parliament.uk/pa/ld200001/ldselect/ldsctech/57/5701.htm)

    House of Commons Select Committee on Science and Technology (2003) ThirdReport (March) (http:www.publications.parliament.uk/pa/cmselect/cmsctech/132/13206.htm)

    Human Genetics Commission (2000) Whose Hands on Your Genes? A discussiondocument on the storage, protection, and use of personal genetic information.London: HGC.

    Human Genetics Commission (2002) Inside Information: Balancing Interests in theUse of Personal Genetic Data. A report by the Human Genetics Commission.London: HGC.

    Institute of Ideas (2002) Science: Can We Trust the Experts? London: Hodder andStoughton.

  • Engendering trust in UK Biobank 291

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    Interim Advisory Group (2003) UK Biobank Ethics and Governance FrameworkBackground Document. Prepared by the Interim Advisory Group on Ethics andGovernance 10 October 2003. (http://www.ukbiobank.ac.uk/documents/egf-background.doc)

    Joss, S. and Durant, J. (eds) (1995) Public Participation in Science: the Role ofConsensus Conferences in Europe. London: Science Museum.

    Kaye, J. (2004) Abandoning informed consent: the case of genetic research inpopulation collections. In Tutton, R. and Corrigan, O. (eds) Genetic Databases:Socio-Ethical Issues in the Collection and Use of DNA. London and New York:Routledge.

    Kaye, L.E. (2000) Who Wrote the Book of Life? A History of the Genetic Code.Standford, CA: Stanford University Press.

    Keller, E.F. (1992) Secrets of Life, Secrets of Death: Essays on Language, Gender andScience. New York and London: Routledge.

    Marshall, G. (ed.) (1994) The Concise Oxford Dictionary of Sociology. Oxford andNew York: Oxford University Press.

    Martin, P. (2001) Genetic governance: the risks, oversight and regulation of geneticdatabases in the UK, New Genetics and Society, 20, 2, 15783.

    Martin, P. and Kaye, J. (2000) The use of large biological sample collectionsin genetics research: issues for public policy, New Genetics and Society, 19, 2,16591.

    MRC (2003) Worlds largest medical data bank gets under way, MRC Network, Issue1 (http://www.mrc.ac.uk/index/public-interest/network/public-newsletter_medical_data_bank.htm)

    MRC, The Wellcome Trust and Department of Health (2003) The UK Biobank: aStudy of Genes, Environment and Health. (http:www.biobank.ac.uk)

    Miller, M.M. and Riechert, B.P. (2000) Interest group strategies and journalisticnorms: news media framing of environmental issues. In Allan, S. Adam, B. andCarter, C. (eds) Environmental Risks and the Media. London and New York:Routledge.

    Miringoff, M.L. (1991) The Social Costs of Genetic Welfare. New Brunswick, NJ:Rutgers University Press.

    Nelkin, D. (1995) Selling Science: How the Press Covers Science and Technology.Revised Edition. New York: W. H. Freeman and Co.

    Nelkin, D. and Lindee, M.S. (1995) The DNA Mystique: the Gene as a Cultural Icon.New York: W. H. Freeman.

    Nelkin, D. and Andrews, L. (1998) Homo Economicus: commercialization of bodytissues in the age of biotechnology, Hastings Centre Report, SeptemberOctober:3039.

    Nisbet, M.C. and Lewenstein, B.V. (2002) Biotechnology and the American media:the policy process and the elite press, 1970 to 1999, Science Communication, 23, 4,35991.

    Office of Science and Technology and The Wellcome Trust (2000) Science and thePublic: a Review of Science Communication and Public Attitudes to Science inBritain. London: The Wellcome Trust.

    Plsson, G. and Hardardttir, K.E. (2002) For whom the cell tolls: debates aboutbiomedicine, Current Anthropology, 43, 2, 271301.

    Parliamentary Office of Science and Technology (2002) The UK Biobank, Postnote,180, July (http://www.parliament.uk/post/pn180.pdf)

  • 292 Alan Petersen

    Blackwell Publishing Ltd/Foundation for the Sociology of Health & Illness 2005

    People Science and Policy Ltd (2002) Biobank UK: a Question of Trust: a ConsultationExploring and Addressing Questions of Public Trust. Report Prepared for The Medi-cal Research Council and The Wellcome Trust, March. London: People Scienceand Policy Ltd. (http://www.wellcome.ac.uk/en/images/biobankuktrust_5973.pdf )

    Petersen, A. (2001) Biofantasies: genetics and medicine in the print news media,Social Science and Medicine, 52, 125568.

    Petersen, A. (2002) Replicating our bodies, losing our selves: news media portrayalsof human cloning in the wake of Dolly, Body and Society, 8, 4, 7190.

    Petersen, A. and Lupton, D. (1996) The New Public Health: Health and Self in theAge of Risk. London: Sage.

    Petersen, A. and Bunton, R. (2002) The New Genetics and the Publics Health.London: Routledge.

    Petryna, A. (2002) Life Exposed: Biological Citizens After Chernobyl. Princeton andOxford: Princeton University Press.

    Radford, T. (2003) Human code fully cracked, The Guardian, 14 April, p. 8.Rose, H. (2001a) Gendered genetics in Iceland, New Genetics and Society, 20, 2, 11938.Rose, H. (2001b) The Commodification of Bioinformation: the Icelandic Health Sector

    Database. London: The Wellcome Trust.Taylor-Gooby, P. (2000) Risk and welfare. In Taylor-Gooby, P. (ed.) Risk, Trust and

    Welfare. Houndmills: Macmillan Press Ltd.The BioIndustry Association (2003) Press releases, 27 May 2003. Position paper on

    UK Biobank (http://www.bioindustry.org/cgi-bin/contents_view.pl)The Wellcome Trust and MRC (2000) Public Perceptions of the Collection of Human

    Biological Samples. Summary Report (http://www.wellcome.ac.uk/en/genome/geneticsandsociety/hg16f002.html)

    The Wellcome Trust and MRC (2002) Protocol for the UK Biobank: a Study of Genes,Environment and Health. February, 2002 (http://www.ukbiobank.ac.uk/documents/draft_protocol.pdf )

    The Wellcome Trust, MRC, and Department of Health (2003) UK BiobankEthics and Governance Framework, Version 1.0, 24 September 2003 (http://www.biobank.ac.uk/documents/egf-comment-version.doc)

    Titmus, R. (1970) The Gift Relationship: from Human Blood to Social Policy.London: Allen and Unwin.

    Turney, J. (1998) Frankensteins Footsteps: Science, Genetics and Popular Culture.New Haven, CT and London: Yale University Press.

    UK Biobank, The Wellcome Trust, MRC and Department of Health (2004) UKBiobank Briefing Note April 2004 (http://www.ukbiobank.ac.uk/documents/long%20briefing%20paper.pdf )

    Van Dijck, J. (1998) Imagenation: Popular Images of Genetics. New York: New YorkUniversity Press.

    Weldon, S. (2004) Public consent or scientific citizenship? What counts as publicparticipation in population-based DNA collections? In Tutton, R. and Corrigan,O. (eds) Genetic Databases: Socio-Ethical Issues in the Collection and Use of DNA.London and New York: Routledge.

    Whitt, L.A. (1998) Biocolonialism and the commodification of knowledge, Scienceas Culture, 7, 1, 3367.

    World Health Organization (2002) Genomics and World Health. Report of theAdvisory Committee on Health Research. Geneva: WHO. (http://www3.who.int/whosis/genomics/genomics_report.cfm)